Aemcolo Gets QIDP, Fast Track Designation for Travelers' Diarrhea

Cosmo Pharmaceuticals announced that Aemcolo (rifamycin SV MMX) has been granted both Qualified Infectious Disease Product (QIDP) and Fast Track Designation by the Food and Drug Administration (FDA).

Aemcolo – a broad spectrum, semi-synthetic, orally administered, minimally absorbed antibiotic – is intended to treat patients with travelers' diarrhea. The tablet is manufactured with the Company's Multi Matrix MMX technology, designed to deliver active pharmaceuticals into the lumen in a delayed fashion that applies the ingredients to the full length of the colon.

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“There have not been any new chemical entities approved to treat colonic infections in years, so resistance to current available drugs is a serious issue,” said Alessandro Della Chà, CEO of Cosmo. “The QIDP and Fast Track designations highlight the importance of treating colonic infections with new chemical entities and Aemcolo's potential to address this unmet medical need.”

In Phase 3 clinical trials involving patients with travelers' diarrhea, Aemcolo was found to be superior to placebo (P=0.0008) and non-inferior to ciprofloxacin.

The company is currently preparing the New Drug Application for Aemcolo for submission to the FDA.